Regional Allergies Southwestern U.S.

Product NDC
57955-2813
11-digit product format
579552813
Labeler code
57955
Product ID
57955-2813_cebb25af-55e4-457c-9ce5-1085feb40106
Type
HUMAN OTC DRUG
Nonproprietary name
Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Arum triphyllum,Arundo mauritanica, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-04-22
Marketing end
0000-00-00
Substance
ADENOSINE CYCLIC PHOSPHATE; AGERATINA AROMATICA ROOT; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; ASARUM CANADENSE ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JACOBAEA VULGARIS WHOLE; JUNIPERUS VIRGINIANA OIL; ONION; PLANTAGO MAJOR WHOLE; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE
Active strength
12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57955-2813DDiscontinued by firm2026-10-05
excluded packagepackage57955-281357955-2813-2DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57955-2813-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57955-2813-2f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57955-2813-2579552813021 BOTTLE, SPRAY in 1 CARTON (57955-2813-2) > 59 mL in 1 BOTTLE, SPRAY2022-04-220000-00-00NoNoCurrent